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This study is a single-center, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of allogeneic peripheral blood stem cell transplantation in the treatment of high-risk peripheral T-cells lymphoma patients achieved complete response (CR) or partial response (PR). Conventional conditioning regimen is adopted while the reduced-intensity conditioning regimens will be preferred. Donor hematopoietic stem cell infusion is performed on day 0. All patients will undergo bone marrow examination on day 14 and day 28 post-transplant, followed by bone marrow examinations every 30 days within the first year after transplantation, and every 60 days within the second year after transplantation. Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro-D-glucose integrated with computed tomography (18F-FDG PET/CT) imaging will be performed every 6 months after transplantation. If disease relapse is suspected during the follow-up period, bone marrow and relapse site examinations will be conducted at any time. The primary study endpoints are the 1-year and 2-year progression-free survival (PFS) rates post-transplant. Secondary study endpoints include the incidence of acute graft-versus-host disease (GVHD) within 180 days post-transplant, cumulative relapse rates at 1 year and 2 years post-transplant, 1-year and 2-year overall survival (OS), graft-versus-host disease-free, relapse-free survival (GRFS), non-relapse mortality (NRM), cumulative incidence of chronic GVHD, and the incidence of Cytomegalovirus (CMV)and Epstein-Barr virus(EBV)reactivation within 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention arm | Experimental | Participants will receive allogeneic peripheral blood stem cell transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allogeneic peripheral blood stem cell transplantation | Other | Patients achieved response to treatment will receive allogeneic peripheral blood stem cell transplantation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1y and 2y-progression-free survival (PFS) | 1-year and 2-year progression-free survival (PFS) rates post-transplant | up to 1 years for the 1y-PFS and up to 2 years for the 2y-PFS |
| Measure | Description | Time Frame |
|---|---|---|
| acute graft-versus-host disease (aGVHD) | acute graft-versus-host disease (aGVHD) within 180 days post-transplant | up to 180 days |
| 1y and 2y-cumulative relapse rates (CIR) | cumulative relapse rates (CIR) at 1 year and 2 years post-transplant |
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Inclusion Criteria:
1. Age between 18 and less than 70 years, regardless of gender 2. Peripheral T-cell lymphoma (PTCL) was diagnosed according to the 2016 WHO criteria and met any of the following criteria:
Related donors must have at least 5/10 matches for HLA-A, -B, -C, -DQB1, and - DRB1.
Unrelated donors must have at least 8/10 matches for HLA-A, -B, -C, -DQB1, and -DRB1.
4.Hematopoietic cell transplantation comorbidity index (HCT-CI) score ≤ 2. 5.ECOG (Eastern Cooperative Oncology Group) performance status: 0-2. 6.Adequate liver, kidney, and cardiopulmonary function, meeting the following requirements:
Serum creatinine ≤ 1.5x ULN (the upper limit of normal).
Cardiac function: Ejection fraction ≥ 50%.
Baseline oxygen saturation > 92%.
Total bilirubin ≤ 2.0 x ULN; ALT and AST ≤ 2.0 x ULN,AKP ≤ 2.0 x ULN
Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 (Forced Expiratory Volume in 1 second) ≥ 50%.
7.Patients must have the ability to understand and be willing to participate in this study and sign an informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xianmin song, MD | Contact | +862163240090 | shongxm@139.com |
| Name | Affiliation | Role |
|---|---|---|
| xianmin Song, MD | Shanghai General HospitalShanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | 200080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29661730 | Background | Cao C, Feng J, Gu H, Tang H, Xu L, Dong H, Dong B, Shu M, Bai Q, Liang R, Zhang T, Yang L, Wang Z, Chen X, Gao G. Distribution of lymphoid neoplasms in Northwest China: Analysis of 3244 cases according to WHO classification in a single institution. Ann Diagn Pathol. 2018 Jun;34:60-65. doi: 10.1016/j.anndiagpath.2017.05.005. Epub 2017 May 12. | |
| 21854649 |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| up to 1 years for the 1y-CIR and up to 2 years for the 2y-CIR |
| 1y and 2y-overall survival (OS) | overall survival (OS) at 1 year and 2 years post-transplant | up to 1 years for the 1y-OS and up to 2 years for the 2y-OS |
| graft-versus-host disease-free and relapse-free survival (GRFS) | graft-versus-host disease-free and relapse-free survival (GRFS) at 2 years post-transplant | up to 2 years |
| non-relapse mortality (NRM) | non-relapse mortality (NRM) at 2 years post-transplant | up to 2 years |
| cumulative incidence of chronic graft-versus-host disease (cGVHD) | cumulative incidence of chronic graft-versus-host disease (cGVHD) at 2 years post-transplant | up to 2 years |
| Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) reactivation | the incidence of CMV and EBV reactivation within 1 year | up to 1 year |
| Yang QP, Zhang WY, Yu JB, Zhao S, Xu H, Wang WY, Bi CF, Zuo Z, Wang XQ, Huang J, Dai L, Liu WP. Subtype distribution of lymphomas in Southwest China: analysis of 6,382 cases using WHO classification in a single institution. Diagn Pathol. 2011 Aug 22;6:77. doi: 10.1186/1746-1596-6-77. |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |